FreeStyle Navigator(R) - Continuous Monitoring
The Advantage Of Continuous Glucose Monitoring
Predicting the effect of food and exercise on blood sugars remains a mystery to many, but now, we can have a better understanding than ever before.
With traditional test strips, even frequent testers may miss significant glucose highs and lows. Measuring your glucose every few hours only gives you a series of “snapshots” of your glucose picture. By reporting your glucose level every minute, day and night, the FreeStyle Navigator system gives you the complete story. Accurately. Precisely. Around the clock.
Every minute counts.
Real-time readings every minute show you where your glucose is going, as it is happening.
Even frequent testers often miss significant glucose fluctuations
Did you know… with traditional methods of monitoring, optimal control (90–130 mg/dL) is achieved for less than 30% of the day.1
Testing 6x a day, this patient would see:
- An average reading of 136 mg/dL
- Standard deviation of 62 mg/dL
- Readings within target 84% of the time
- Only 1 hyperglycemic episode detected
Continuous monitoring reveals readings traditional monitoring may
miss.
With continuous monitoring over 24 hours, the same patient would see:
- An average reading of 152 mg/dL
- Standard deviation of 85 mg/dL
- Readings within target 62% of the time
- Several episodes of hypo- and hyperglycemia detected
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Bode BW, Schwartz S, Stubbs HA, Block JE. Glycemic characteristics in continuously monitored patients with type 1 and type 2 diabetes. DiabetesCare. 2005;28:2361-2366. |
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Safety Information: Users should read all of the instructions in the User's Guide before using FreeStyle Navigator® Continuous Glucose Monitoring System. Adjustments to treatment should be done under the guidance of the user's healthcare team.
Indications for Use: The FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator® Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on results and alarms from the FreeStyle Navigator® Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator® Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.
The FreeStyle Navigator® Continuous Glucose Monitoring System provides real-time readings, graphs, trends, and glucose alarms directly to the user. The FreeStyle Navigator® Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid healthcare professionals in evaluating glucose control. The FreeStyle Navigator® Continuous Glucose Monitoring System is available only by prescription.
Contraindications: The FreeStyle Navigator® Continuous Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).
Prescription Device: Federal law restricts the sale of this device by or on order of a physician.
Warnings/Precautions: Infection, inflammation, or bleeding at the glucose sensor insertion site are possible risks of inserting a sensor into your skin. If you believe your results are not reliable, or are inconsistent with how you feel, perform a blood glucose mode test to measure your glucose. If the problem continues, discard the old sensor and insert a new sensor. Performance of the system under conditions of fluctuating hydration levels such as during renal dialysis has not been evaluated. Unintended dislodging of the sensor due to excessive perspiration, exercise, or bumping, may cause unreliable or no results without warning. A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined. Performance of the FreeStyle Navigator system has not been evaluated in pregnant women.
DOC13789_Rev-A 01/08
